ibuprofen tablet film coated

HOW SUPPLIED

IBUPROFEN Tablets, USP are available in the following strengths: The 400 mg tablets are film-coated clear, round shaped, white tablets, debossed “C5” on one side and plain on the other side. They are available as follows: Bottles of 20 Tablets NDC #68788-8201-2 Bottles of 28 Tablets NDC #68788-8201-8 Bottles of 30 Tablets NDC #68788-8201-3 Bottles of 50 Tablets NDC #68788-8201-5 Bottles of 60 Tablets NDC #68788-8201-6 Bottles of 90 Tablets NDC #68788-8201-9 Bottles of 100 Tablets NDC #68788-8201-1 Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Avoid excessive heat 40°C (104°F). Manufactured by: Contract Pharmacal Corp. 165 Oser Avenue Hauppauge, NY 11788 USA Distributed by: Florida Pharmaceutical Products, LLC 6111 Broken Sound Pkwy NW Suite 160 Boca Raton, FL 33487 Toll Free Number: 1-800-315-0985 14464-04-21 Repackaged By: Preferred Pharmaceuticals Inc. MEDICATION GUIDE Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) What it the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? NSAIDs can cause serious side effects, including: • Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase: • with increasing doses of NSAIDs • with longer use of NSAIDs Do not take NSAIDs right before or after a heart surgery called a "coronary artery bypass graft (CABG)." Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack. • Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines: • anytime during use • without warning symptoms • that may cause death The risk of getting an ulcer or bleeding increases with: • past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs • taking medicines called "corticosteroids", "anticoagulants", "SSRIs", or "SNRIs" • increasing use of NSAIDs • longer use of NSAIDs • smoking • drinking alcohol • older age • poor health • advanced liver disease • bleeding problems NSAIDs should only be used : • exactly as prescribed • at the lowest dose possible for your treatment • for the shortest time needed What are NSAIDs? NSAIDs are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as different types of arthritis, menstrual cramps, and other types of short-term pain. Who should not take a NSAIDs? Do not take NSAIDs: • if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs • right before or after heart bypass surgery Before taking NSAIDs, tell your healthcare provider about all your medical conditions, including if you: • have liver or kidney problems • have high blood pressure • have asthma • are pregnant or plan to become pregnant. Taking NSAIDs at about 20 weeks of pregnancy or later may harm your unborn baby. If you need to take NSAIDs for more than 2 days when you are between 20 and 30 weeks of pregnancy, your healthcare provider may need to monitor the amount of fluid in your womb around your baby. You should not take NSAIDs after about 30 weeks of pregnancy. • are breastfeeding or plan to breast feed Tell your healthcare provider about all of the medicines you take, including prescription or over the-counter medicines, vitamins or herbal supplements. NSAIDs and some other medicines can interact with each other and cause serious side effects. Do not start taking any new medicine without talking to your healthcare provider first. What are the possible side effects of NSAIDs? NSAIDs can cause serious side effects, including: See "What is the most important information I should know about medicines called Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)?" • new or worse high blood pressure • low red blood cells (anemia) • heart failure • life-threatening skin reactions • liver problems including liver failure • life-threatening allergic reactions • kidney problems including kidney failure • Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness. Get emergency help right away if you have any of the following symptoms : • shortness of breath or trouble breathing • slurred speech • chest pain • swelling of the face or throat • weakness in one part or side of your body Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms: • nausea • vomit blood • more tired or weaker than usual • there is blood in your bowel movement, or it is black and sticky like tar • diarrhea • unusual weight gain • itching • skin rash or blisters with fever • your skin or eyes look yellow • swelling of the arms, legs, hands and feet • indigestion or stomach pain • flu-like symptoms If you take too much of your NSAIDs, call your healthcare provider or get medical help right away. These are not all the possible side effects of NSAIDs. For more information, ask your healthcare provider or pharmacist about NSAIDs. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1- 800-FDA-1088 . Other information about NSAIDs • Aspirin is an NSAID but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines. • Some of NSAIDs are sold in lower doses without a prescription (over-the-counter) Talk to your healthcare provider before using over- the-counter NSAIDs for more than 10 days. General information about the safe and effective use of NSAIDs Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use NSAIDs for a condition for which it was not prescribed. Do not give NSAIDs to other people, even if they have the same symptoms that you have. It may harm them. If you would like more information about NSAIDs, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about NSAIDs that is written for professionals. For more information, call/contact: 1-631-231-4610 This Medication Guide has been approved by the U.S. Food and Drug Administration Manufactured by: Contract Pharmacal Corp. 165 Oser Avenue Hauppauge, NY 11788 Distributed by: Florida Pharmaceutical Products, LLC 6111 Broken Sound Pkwy NW Suite 160 Boca Raton, FL 33487, Toll Free Number: 1-800-315-0985 14517-04-21 Repackaged By: Preferred Pharmaceuticals Inc.

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